GAMP 5
GAMP 5 Rationale.
The acronym GAMP 5 refers to "Good Automatic Manufacturing Practices issue 5", document. Although GAMP 5 has no legal standing and is purely advisory, it does contain information and methodologies that are of interest to anyone engaged in validation activities within the cGMP regulated environment. However; the reality of the situation is that our regulatory requirements for cGMP are published in 21 CFR Part 820/210/211/11 and other government issued edicts.
A company compliant with its regulatory requirements will have written its own equivalent of the GAMP 1/2/3/4/5 series. Only difference is; it will have titled them, Company Regulatory Practices and Procedures (CRPP) (or something similar), and they will be specific to the company.
All the GAMP 5 guidance documents have been authored by committees, and not everybody in a committee can get their own say. So there is often contentious material, statements and or methods included.
GAMP 5 compliance documents should be closely studied and the requirements, as applicable to your company’s activities, should be extrapolated and developed into your quality policies and procedures manual. This manual should then be the definitive authority on all Validation Online company matters.
The GAMP 5 committee has tried to be all things to all people, and in the opinion of many fail to be specific enough to be used as anything other than a discussion document. On the other hand; the work put in to developing your own RPP pays endless dividends, since it will document the responsibilities of all personnel, along with defining the scope of all company qualification processes. It should become a master reference document and its use will ensure that all your company regulatory activities will be compliant with the appropriate regulations.
GAMP 5 Categories Concepts.
The GAMP 5 standard, allows a degree of flexibility when applying validation to the great variety of medical devices, processes, and manufacturing facilities, since it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for validation Online in GAMP 5 demonstrates. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation.
GAMP 5 Category Evolution.
The GAMP 5 Guide for Validation of Automated Systems, has been released in December 2001 in Amsterdam. The guide aims to assist companies in the healthcare industries to achieve validated and compliant automated systems.
It provides guidance to the suppliers of those GAMP 5 automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support GAMP 5 validation concepts.
The GAMP 5 guidance document is a significant advance on previous versions of this widely accepted guidance on validation Online of automated systems. The complete document has been revisited and refined to reflect current regulatory expectations and good practice. It has been considerably enhanced and restructured, following principles and recommendations defined by the Industry Board. However one must remember GAMP 5 is only a guide.
GAMP 5 Document Security
The regulators mandate that all good automated manufacturing processes and methods used to produce a regulated product must be documented and be company approved. In the majority of cases this requirement is fulfilled by using a standard operating practice documents (SOP’s) to encapsulate the GAMP 5 methodology chosen. The original SOP once approved will reside in a safe and secure location in change control (this is a regularly audited requirement).
It really depends on your company practices and procedure (which also must be documented and approved) as to whether the GAMP 5 doctrine is in electronic format with; or without, e signatures. Security of this document is initially by physical access and then by a series of cascading passwords. The cascade must ensure that the person accessing the document can only access the document to the level that the company has authorized. Continuous control of all issued copies must be maintained by change control.
Change control must at all times (another regularly audited point) know the location of all the SOP copies in circulation and must have the capability to be able to recall them for incorporation of amendments or destruction.
As an auditor, I have audited for these features for many years and I have never found a case of un-authorized SOP changes. I have found many cases where the operators failed to follow the SOP containing the GAMP 5 procedures. This always puzzles me; why shoot yourself in the foot over something so obvious, but a glance through the warning letters shows this is still one of the major causes of FDA citations.
21 Years of retailing cGMP - 35k templates supplied to the industry.
Validation Risk Assessment (Issue 11) $125.00
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
Combined IQ-OQ-PQ Computer (Issue-4) $159.00
This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
Operational Qualification, SOP & Protocol (Issue 10.) $115.00
You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.
Computer Combined IQ-OQ-PQ (Issue 3) -- $159.00
Most Popular Download
This
combination IQ-OQ-PQ protocol has been produced in response to several hundred reader
suggestions we received in our ‘Suggestions Section’. It has been carefully
designed to make it the preferred choice for Process and Laboratory stand alone
equipment. It is interactive, easy to use, compliant with cGMP & GAMP 5. and suitable for all mixes of
equipment with and without software.
Computer User Requirements Specification (Issue 5.) -- $115.00
The document that sets the standard, and specifies your computer regulatory requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ and is compliant with cGMP and GAMP 5.
12000008_4Q_Equip_
Package -- $499.00
This quite revolutionary two document
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equipment used in a regulated facility. A lot of effort by Validation Online has gone into
ensuring that repetitive instructions and actions have been designed out
and innovative and intuitive risk-based methodologies have been
incorporated.
Both documents
are prefaced with a methods' Standard Operating Practice (SOP) document.
These SOP’s lead you through the task of converting these highly
detailed templates into your very own company bespoke protocols. The
hyperlinks and cross-references within the package are; not only unique
but also highly cost-effective and intuitive to use. Each document is
preloaded with the test scripts (complete with acceptance criteria). All
test and inspection scripts are written in MS word and are compliant with cGMP's and GAMP 5.
Definitive Validation Manual (Issue 3.) -- $1,160.00
This Corporate Validation Manual (CVM) is supplied loaded to a memory stick (MS) and complete with the attachments that are listed in the graphics below. These high quality documents and protocols are all constructed in Microsoft Word. Each document is preceded by an SOP which prompts you through the procedure of populating and then customizing the template, into your own bespoke company document. This MS has real documents, detailed, compliant and interactive, but most of all - Highly Cost Effective compliant with cGMP's and GAMP 5. These documents have evolved through over thirty years of joint validation expertise, they will free up a lot of your time and enable you to deliver your validation projects and tasks on time.
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